Summary
A new study undergoing in Tel Aviv – Dana-Dwek Childrens Hospital Neurology Unit, will try to provide evidence based data for physicians and patients, who consider using an FES device, with regards to a better selection of patient who could profit from this device and the expected benefits.
Methods
Study population: 20 patients with CP will participate. Inclusion criteria: children above age of 6 years, with CP hemiplegia (GMFCS I/II), with drop foot and dynamic contracture of the ankle on examination, who are being treated at the CP clinic in the Tel Aviv Dana-Dwek Children Hospital. Exclusion criteria: Children with fixed contracture of ankle joint (passive range of motion< 0 degree); children who had orthopedic surgery to the lower extremity or had botulinum toxin injection to the plantar or dorsiflexor muscles within 6 months prior to the study; children who cannot tolerate the electrical stimulation delivered by the device.
Results
STUDY DESIGN: open label study. FES device used (WalkAide; Innovative Neurotronics, USA) delivers electrical stimulation to the common peroneal nerve, triggered by an accelerometer and a tilt sensor, to improve dorsiflexion and foot clearance during swing phase. The duration of the study – 5 months: First month is an adaptation period and 4 months of daily using of the device – intervention period. The aim is a "minimal threshold" use of at least 5 days per week, 4 hours per day and 1500 steps per day. Each child will go through: Medical interview and neurological and physical therapist examination (Definition of passive range of ankle dorsiflexion, modified Ashworth scale test), Motor function tests: "6 min walk test", Gross motor function measure (GMFM),"Timed up and down stairs test", walking on a ramp, with and without the FES device.
Gait analysis test with and without FES device (ankle kinematics and analysis of foot clearance parameters). Parents will complete questionnaires on the quality of life, and frequency of falling + the compliance to the FES. Gait analysis will be performed by: Hasomed RehaGait at adaptation period and A 3D gait analysis Vicon MX Giganet motion analysis system at intervention period. Kinetic data will be collected using four force plates. For each child, the results of the gait analysis and the functional tests will be compared between the baseline (beginning of intervention period) and final parameters using the paired t-test analysis.
Conclusion
Study is still undergoing. At the OT-World congress we have described the experience accumulated at that point in time, including preliminary results.
References
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